Quality consistency of Liuwei Dihuang concentrated pills was evaluated by high performance liquid chromatography combined with stoichiometry
Objective:To establish a quality consistency assessment method to evaluate the consistency of product quality of Liuwei Dihuang concentrated pills(LDCP)among different manufacturers.Methods:Firstly,high performance liquid chromatography(HPLC)was used to determine the content of the six index components in LDCP,and analyze the content differences between different batches of the same manufacturer and the current product quality of different manufacturers.Secondly,quality consistency parameters,i.e.,intra-batch content consistency differences(PA),inter-batch content consistency differences(PB),and fingerprint similarity(PC),were constructed to assess the consistency of product quality among the different manufacturers.And last-ly,the consistency parameters were taken as the variables and subjected to the principal component analysis(PCA)to classify the consistency of the LDCP samples of the seven manufacturers to be fitted and differentiated.Results:The contents of the six index components in thirty-five batches of LDCP samples from seven manufac-turers totaled 1.48-2.99 mg per pill,the RSDs of the contents of different components were 4.9％-29.7％,and the consistency parameters of the seven products were 4.2％-15.1％for PA,26.4％-49.5％for PB,and 92.9％-98.2％for Pc.There were some differences in the homogeneity of contents in samples from different manufacturers,and the contents of the product varied significantly between batches,with P value of 64.5-75.8,indicating that the difference in the consistency of samples from different manufacturers was relatively small.But under certain conditions,the seven manufacturers can be classified into three categories,with B and J as a catego-ry,Z and R as a category,and X,F,and S as a category.Conclusion:This study provides a simple and effec-tive method for monitoring and distinguishing the quality consistency of commercially available LDCP products,and the experimental results can provide a reference for the sample quality homogeneity of LDCP manufacturers.
NETL
NSTL
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